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An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

Sponsor
Yuhan Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05835518
Collaborator
(none)
1,000
Enrollment
1
Location
42.2
Anticipated Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
    Actual Study Start Date :
    Jan 26, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS [52weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Men and women between the ages of 19 and 75 at the time of consent

    2. Those diagnosed with RA or AS at least 3 months prior to the time of study registration

    3. A person who is scheduled to be prescribed Adaloce in the opinion of the attending physician

    4. Patients who have never received Adaloce

    5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study

    Exclusion Criteria:

    1. Patients with hypersensitivity to this drug or its components

    2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection

    3. Patients with moderate to severe heart failure (NYHA class III/IV)

    4. Patients who are judged to be inappropriate for Adaloce administration a according to the approved conditions

    5. Patients who are not suitable for participation in this study according to the judgment of the researcher

    6. Patients participating in other drug clinical trials (subjects participating in Adaloce PMS cannot participate in this study)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Daegu Catholic University Medical Center Daegu Korea, Republic of

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    • Principal Investigator: Jeongyoon Choi, PI, Daegu Catholic University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT05835518
    Other Study ID Numbers:
    • YMC049
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuhan Corporation
    The Efficacy and Safety of Adalloce
    Additional relevant MeSH terms:
    Spondylitis
    Arthritis
    Arthritis, Rheumatoid
    Spondylarthritis
    Spondylitis, Ankylosing

    Study Results

    No Results Posted as of Apr 28, 2023